Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Wednesday, December 2, 2015 Daily Archives

Vetter has received the status of Authorized Economic Operator Full (AEO-F) from the European Union confirming Vetter reliability, solvency, and high safety standards in international trade. Vetter’s customers worldwide will now benefit from shorter transit times and lower costs with the usual high product quality. The internationally accepted AEO-F certification (Authorized Economic Operator – Customs simplifications/Security) will facilitate the import of drugs in third countries. The certificate confirms the compliance of high safety requirements throughout the entire supply chain of…

Enzo Life Sciences continues to expand its ELISA portfolio. A leading manufacturer of high quality ELISAs, Enzo continues to invest in developing immunoassays with the launch of their new VEGF ELISA Kit. Vascular Endothelial Growth Factor (VEGF), originally known as vascular permeability factor (VPF), is a family of proteins that stimulate vasculogenesis and angiogenesis. The VEGF family comprises five members: VEGF-A, VEGF-B, VEGF-C, VEGF-D and PGF (placenta growth factor) 1-3. Being the first of the VEGF family members to be…

This webcast features: Chris Shields, Director of Global Product Validation Services at Saint-Gobain Life Sciences. Extractable testing is traditionally performed by single-use suppliers, and while not required by industry regulations, it is the drug manufacturer’s expectation that this information form part of a product’s data package. Extractable and leachable testing is designed to determine the chemical compounds that may migrate into the customer’s fluid from the single-use product’s fluid contact layer. Extractable testing utilizes aggressive but relevant test conditions, while…